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FDA warns against ovarian cancer screening tests

12 September 2016

By Anastassia Bolotkova

Appeared in BioNews 868

The US Food and Drug Administration (FDA) has warned that it does not recommend the use of any currently available ovarian cancer screening tests to detect the disease.  

In a recently issued safety communication to both medical professionals and the general public, the FDA cautioned that such screening tests are unreliable and may generate false-positive or false-negative results. This may lead to unnecessary follow-ups and medical treatment for some women, or delay effective treatment for women who do have ovarian cancer.

'Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,' the FDA concluded, after reviewing available clinical data and recommendations from healthcare professional societies and the US Preventative Service Task Force.

Several companies have developed and marketed screening tests for ovarian cancer. The most widely used test aims to detect levels of CA 125 protein in the blood as certain cancers, including ovarian cancer, can cause an increase of CA 125. One such test, ROCA, produced by the pharmaceutical company Abcodia, has been approved for use in five US states. However, such tests are unreliable as many other non-tumour related diseases can also increase levels of CA 125.

The FDA announcement was welcomed by the Ovarian Cancer Research Fund Alliance. 'From what we know anecdotally, in spite of the fact that CA 125 isn't really meant to be used that way, many women who are concerned about the risk of ovarian cancer are getting the test every year,' said Sarah DeFeo, vice-president of scientific affairs for the alliance.

The FDA warns that use of such tests can lead to people receiving a false-positive result, suggesting the presence of cancer when it is not there. As a result, women may undergo unnecessary screening, treatment or surgery. Alternatively, women who do have ovarian cancer may receive a false-negative result indicating absence of cancer, which could result in delayed treatment. This is especially problematic for women who have no symptoms but who are at higher risk of developing ovarian cancer, including women who have reached menopause, who have a family history of ovarian cancer, or who possess the BRCA1 or BRCA2 gene mutations.

In the US, ovarian cancer is the fifth most common cancer among women and it is predicted that 22,000 women will be diagnosed with the disease in 2016. Currently, FDA has not approved the use of any ovarian cancer screening test and recommends that those who are at higher risk should ask their doctor for a referral to a genetic counsellor, gynaecologic oncologist or other specialist.

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